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FDA to Prioritize Biosimilars in Plan to Roll Out This Month

The Food and Drug Administration in the next few weeks will unveil a program to streamline
approvals for complex drugs—commonly referred to as biosimilars—in an attempt to stem
skyrocketing drug prices and improve drug accessibility for patients.

Scott Gottlieb, head of the agency, hit on all the industry buzzwords in his address
to a crowd of food and drug policy wonks at a Food and Drug Law Institute conference
May 2. Drug prices are out of hand and policy loopholes are being utilized by drug
companies for the wrong reasons, Gottlieb said in his speech.

The agency has already ramped up its approval rates for generic drugs. Now, it will
take a closer look at streamlining the approval process for biosimilars, which are
complex drugs that are highly similar to and can be substituted for a biologic drug
already on the market. The plan, which will attempt to increase competition between
drug manufacturers and increase the number of biosimilars on the market, will be announced
within the month, an FDA representative told Bloomberg Law.

“The commissioner believes the market would benefit from additional products on the
market,” the representative said. But issues within the biosimilar market are unique—payers
and branded manufacturers are “colluding to keep the biosimilars market from developing,”
said the representative, who asked not to be named. That adds a layer of complexity
to the way the FDA regulates those drugs.

One way to crack down on that collusion is to make it easier to establish equivalence
for biosimilars so there are more of them available. “More options put more pressure
on insurers and pharmacy benefit managers to put the biosimilars on the formulary,”
which is a list of prescription drugs covered by a prescription drug plan, the representative
said. The limited number of biosimilars now makes it easy to keep them off that list.

Need Better Biosimilar Understanding

But a better biosimilar plan would require the FDA to have “a more sophisticated”
understanding of the two “levels” of biosimilars, Peter Pitts, president of the Center
for Medicine in the Public Interest, told Bloomberg Law.

All biosimilars
approved in the U.S. are technically “level one,” which means there are very few differences
in the molecular makeup of the biosimilar and its established counterpart. “Level
two” biosimilars don’t exist in the U.S. Those are complex drugs that have the same
effect in clinical trials as the original drug the biosimilar is copying.

“A step forward is to understand the pathways to biological interchangeability,” Pitt
said, referring to the term used to describe two formulas a patient can switch between
without problems. But the different “levels” within the science behind biosimilar
drugs is complicated, and the FDA has had a hard time keeping up, he said.

Biosimilars are also more expensive, and creating a biosimilar doesn’t lower the price
of the drug as much as creating a generic version of a drug does. When a generic version
of a brand-name drug comes out, the price of the drug goes down about 80 percent,
Pitt said. For biosimilars, that list price goes down about 30 percent.

Biosimilars are more complex and more prone to cause adverse reactions, so they require
large clinical trials to be approved by the FDA. Their complexity is what makes them
significantly more expensive to develop than generic drugs. In a March speech, Gottlieb
estimated biosimilars take about $100 million to $250 million to develop versus the
roughly $10 million it would take to develop a generic version of a drug.

“For our system to continue to work, innovation has to be balanced with competition
and access,” Gottlieb said.

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